EUCTR2005-001612-49-GB进行中（未招募）1 期
Randomized, multicenter, double-blind, placebo-controlled, two-arm parallel group trial of rimonabant 20-mg od, for inhibition of atherosclerosis progression assessed by carotid artery intima-media thickness (CIMT), in overweight patients with additional risk factors - AUDITOR
Sanofi-Synthelabo Recherche0 个研究点目标入组 600 人开始时间: 2005年7月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Written and signed informed consent
- •Age = 55 years
- •Abdominal obesity defined by waist circumference
- •> 88 cm (35 inches) in women or > 102 cm (40
- •inches) in men
- •Metabolic syndrome diagnosed on the basis of at
- •least two of the following additional risk factors:
- •- Triglyceride level = 150 mg/dL (1.69 mmol/L)
- •- HDL cholesterol < 40 mg/dL (1.03 mmol/L)
- •[men] or 50 mg/dL (1.28 mmol/L) [women]
- •- Fasting glucose = 110 mg/dL (6.1 mmol/L)
- •- High blood pressure (= 140 mmHg systolic
- •and/or = 90 mmHg diastolic) at Screening
- •visit, or current treatment by anti-hypertensive
- •Ultrasonographic evidence at Screening
- •quantitative B-mode ultrasound imaging of a
- •minimal CIMT measurement = 0.7 mm in either of
- •the far walls of the common carotid artery, and
- •maximal CIMT measurement < 3 mm in any
- •carotid artery segment
- •All 6 carotid artery segment B-mode ultrasound
- •images must allow for CIMT measurements
- •Screening CIMT recording deemed to be of
- •acceptable CIMT image quality, and demonstrating
- •adherence to the CIMT interrogation protocol, as
- •determined by the Imaging Core Laboratory’s
- •assessment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •History of very low-calorie diet or surgical
- •procedures for weight loss (eg, stomach stapling,
- •bypass) within 6 months prior to Screening visit
- •Obesity of known endocrine origin
- •Uncontrolled diabetes, ie with HbA1c >10%
- •Anticipated survival < 27 months
- •Presence of any severe medical or psychological
- •condition, that in the opinion of the Investigator
- •would compromise the subject’s safety or
- •successful participation in the study
- •Presence of any other condition (e.g. geographic,
- •social…) actual or anticipated, that the Investigator
- •feels that would restrict or limit the subject’s
- •participation for the duration of the study
- •Receipt of any investigational treatment (drug or
- •device) within 30 days prior to Screening
- •Previous participation in a rimonabant study
- •Total occlusion of any carotid artery segment
- •Previous history of carotid intervention (carotid
- •surgery, percutaneous carotid intervention…)
- •Patient considered at high risk of carotid
- •intervention during the next 27 months (eg
- •presence of ulcerative plaque or hemodynamically
- •significant stenosis)
- •Pathology in near and / or far wall that causes
- •acoustic shadowing of far wall CIMT in any
- •arterial segment
- •Inability to define the carotid flow divider on either
- •Anatomic variables (e.g., obscured vessels due to
- •the mandibular angle, too deep or tortuous vessels)
- •making CIMT measurement impossible in any
- •arterial segment
研究者
相似试验
进行中（未招募）
1 期
Randomized, multicenter, double-blind, placebo-controlled, two-arm parallel group trial of rimonabant 20-mg od, for inhibition of astherosclerosis progression assessed by IVUS (IntraVascular UltraSounds), in overweight patients with clustering risk factors. - STRADIVARIUSOverweight patients with clustering risk factors scheduled for coronary angiography. (Prevention of atherosclerosis progression assessed by IntraVascular UltraSounds).MedDRA version: 7.0Level: LLTClassification code 10003601EUCTR2004-003929-27-ESSanofi-Synthelabo-Recherche800
进行中（未招募）
1 期
Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20)Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)MedDRA version: 18.1 Level: PT Classification code 10061811 Term: Demyelinating polyneuropathy System Organ Class: 10029205 - Nervous system disordersEUCTR2011-003448-28-GBCSL Behring GmbH276
进行中（未招募）
1 期
Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20)Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)MedDRA version: 19.0Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem Organ Class: 10029205 - Nervous system disordersEUCTR2011-003448-28-PLCSL Behring GmbH350
进行中（未招募）
不适用
A study to evaluate how safe is and how well SMO.IR works when given in 4 dose regimens for the maintenance of alcohol abstinence in recently abstinent alcohol-dependent patientsmaintenance of alcohol abstinence in recently abstinent alcoholdependent patientsMedDRA version: 14.1Level: SOCClassification code 10037175Term: Psychiatric disordersSystem Organ Class: 10037175 - Psychiatric disordersEUCTR2011-000575-14-ITD&A PHARMA495
进行中（未招募）
1 期
Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20)Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)MedDRA version: 18.1Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem Organ Class: 10029205 - Nervous system disordersEUCTR2011-003448-28-CZCSL Behring GmbH350